CN107427660B

CN107427660B - Skull tightening device

Info

Publication number: CN107427660B
Application number: CN201680012899.6A
Authority: CN
Inventors: 迈克尔·卡姆·伦; 丹尼尔·奥; 希兰·洲汉; 阿什利·霍尔; 安德鲁·雅法迪斯; 纳达拉沙·维斯维什瓦拉
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-03-03
Filing date: 2016-03-03
Publication date: 2020-04-24
Anticipated expiration: 2036-03-03
Also published as: US10315001B2; CA3016405A1; CA3016405C; US20170151408A1; CN107427660A; EP3265159B1; EP3265159A4; EP3265159A1; WO2016141210A1

Abstract

Headgear for securing a patient airway interface device to a patient's head comprising a concave partial helmet having an outer surface and an inner surface, and having a left lateral element, a right lateral element, a top portion, and a rear portion, wherein the left and right lateral elements are spaced apart at a front half of the concave partial helmet by a top front half of the concave partial helmet and a gap between the left and right lateral elements.

Description

Skull tightening device

Cross Reference to Related Applications

This application claims priority from U.S. provisional application No. 62/127,628 entitled "skull fastener" filed 3/2015, the contents of which are incorporated herein in their entirety.

Statement regarding federally sponsored research or development

Not applicable.

Incorporation by reference of material submitted by optical discs

Not applicable.

Copyrighted material

Not applicable.

Background

One aspect of the present invention relates to positive airway pressure support systems, and more particularly to a patient interface device for communicating a flow of gas to an airway of a user, wherein the patient interface device includes headgear adapted to support an airway interface on the user, and to methods of using such patient interface systems.

Aspects of the present invention generally relate to components of a medical system for delivering gas to or from an airway of a patient. In one particular embodiment, the invention relates to a headgear, a patient interface, or a combination of a headgear and a patient interface as part of a medical system for delivering breathable gas to and/or from a patient, or as part of a respiratory system.

Human infants are often described as having to breathe through the nose because they preferentially breathe through their nose rather than the mouth. However, most infants are able to breathe through their mouths when the nose is blocked. Continuous Positive Airway Pressure (CPAP) is a commonly used non-invasive treatment for various respiratory diseases in neonates, children, and adults. Nasal masks and cannulas that (in part) form the patient interface of some respiratory systems are typically held in place on the patient's head by elastic straps, buckles, or retention systems that typically include Velcro straps and adhesive tape. For example, adhesive patches or other skin attachment systems are used to position the mask and cannula on the face of the infant. When the adhesive is applied and removed multiple times, the pressure exerted by the tensioned chordae and tapes placed on the surface of the existing tethering system causes distortion, skin reactions, skin abrasion or damage to the facial and cranial structures. To overcome the deleterious effects of the current CPAP constraints, an innovative medical system is employed. The medical system includes a helmet that provides reduced or minimal pressure on the skull or facial features (e.g., cheeks) of the patient and minimizes pressure along the skull structure.

A problem with neonatal or infant CPAP and endotracheal patient devices in use is that the device includes a strap that binds the nasal cannula and cap/headgear to the facial bone structure to securely fasten the device to the face. The strap used to attach the nasal cannula or mask to the face has a narrow width of about 0.75cm at the narrow end to about 1cm at the distal end. When the strap is in use, the strap is stretched under tension around the head. The tension forces place a great deal of pressure on a limited area of the face (cheeks). Typically, the respiratory system is used by neonates for long periods (months) and is worn for many hours each day. There are many examples of strap restraint systems that are connected to gas delivery masks and used to hold a gas delivery mask, such as a CPAP mask, to the face of a patient, such as a neonate, where the same degree of (constant) pressure is applied to an active area of the face, causing facial distortion and resulting facial deformation over time. This is especially problematic in newborns with deformable bone and tissue. The aforementioned problems are caused by the constant pressure transmitted to the face by the small surface area of the straps or cuffs that surround the head and directly contact the face (e.g., cheeks) of the newborn to secure the mask or nasal cannula to the face.

Disclosure of Invention

One embodiment of the present invention provides headgear for securing a patient airway interface device to a patient's head comprising a concave partial helmet having an outer surface and an inner surface, and having a left lateral element, a right lateral element, a top portion, and a rear portion, wherein the left and right lateral elements are spaced apart at a top front half of the concave partial helmet by a gap between the front half of the concave partial helmet and the left and right lateral elements. When on the patient's head, the top of the concave partial helmet terminates at the forehead of the patient's head with the front surface of the top of the concave partial helmet adjacent the forehead having a stabilizer for supporting the bushing. The left and right lateral elements are configured to terminate on either side of the patient's face proximate the cheek without directly contacting the cheek. The portions of the right and left transverse elements proximate the cheeks include openings that allow the strap to pass from the outer surface to the inner surface. The portion of the concave partial helmet inner surface configured to cover the back half of the skull when the headgear is in use is spaced from the patient's head by the pliable material attached to the inner surface. Optionally, the top of the concave partial helmet includes an open portion to allow access to the fontanelle area of the patient's head. The left and right cross members of the female partial helmet may cover the ears and include a removable noise-inhibiting cover that when removed leaves an opening at a location above the ears of the left or right cross member. The rear portion of the concave partial helmet is configured to cover the occipital region of the patient's head. The left transverse element of the female partial helmet and the right transverse element of the female partial helmet may be movably connected to the rear part of the partial helmet by means of a connector. For example, the connector may be a hinge. The portion of the inner surface of the concave partial helmet configured to cover the back of the skull when the headgear is in use may be spaced from the patient's head by a pliable material attached to the inner surface. For example, a pliable material may be releasably attached to the inner surface, the pliable material remaining adapted to the natural shape of the head during use. The pliable material is covered by a washable liner.

Another embodiment of the present invention is a gas delivery system adapted to provide a flow of gas to an airway of a patient, the system comprising headgear for securing a patient airway interface device to the head of the patient, the headgear comprising a concave partial helmet as described herein. A gas delivery conduit is attached to the partial helmet, the gas delivery conduit including a patient airway interface having an airway interface support for delivering gas under pressure to the nares, the airway interface support having a strap for securing the patient airway interface to the concave partial helmet at a location relative to the nares of the patient. The strap is fastened to the female partial helmet through an opening in the left transverse element of the female partial helmet and the right transverse element of the female partial helmet. The opening is a plurality of openings at different locations on the right cross member of the concave partial helmet and the left cross member of the concave partial helmet that are used to select an optimal angle for securing the patient airway interface device relative to the patient's nares. The gas delivery conduit is attached to the concave partial helmet by a bushing attached to the stabilizer at a front portion of the concave partial helmet, the bushing having an opening through which the gas delivery conduit passes at an angle to the bushing, which enables the patient airway interface at the first end of the gas delivery conduit to be directly adjacent to a nostril of a patient wearing the concave partial helmet. A gas delivery conduit at the second end extends over the liner. The eye shield can be tethered to the concave partial helmet when needed by the patient.

Another embodiment provides a method of securing a patient airway interface to a patient's head, comprising the steps of: attaching a conduit for transporting gas under pressure to a patient wearing headgear as described herein, wherein the conduit has a first end that is an airway interface of the patient that provides gas under pressure to the patient's nares when adjacent to the nares and a second end that extends above a bushing attached to the top of a concave partial helmet as described herein when on the patient's head. The patient airway interface is secured adjacent the patient's nares with straps that are disposed around the concave partial helmet and attached to the patient airway interface at an angle to hold the patient airway interface properly adjacent the nares for delivery of gas under pressure to the patient's nares. The conduit is attached at its second end to a hose for transporting gas under pressure. The strap is threaded through an opening in the helmet cross-member from the helmet inside to the helmet outside, wherein the strap stays outside the helmet after passing through the opening. The patient airway interface may be disposed above or below, left to right, and toward or away from the nares.

One aspect of an embodiment of the present invention provides a helmet for positioning on a skull of a patient. The helmet partially covers the skull and comprises side cross members thereon as a base to which straps are connected that hold in place a mask or nasal interface for supplying gas to the patient. In contrast to the prior art, the straps that hold the mask to the face are no longer placed around the skull, pressure is applied to the skull and directly against the skull to pull the mask onto the face, but the straps are secured to the helmet by the side cross members of the helmet, or stretched around the helmet, when used to secure the mask or nasal interface to the patient's face. Thus, the helmet serves to relieve the pressure exerted by the strap under tension directly on the skull and face in use. Helmets are used, for example, for neonates to reduce pressure on cranial structures and to support gas delivery conduits in position for gas delivery to the airways, such as the nostrils, of a patient.

Another aspect is to provide a helmet with minimal pressure on the skull or cranial structures because the rigid structure of the helmet does not directly contact the maxillofacial region.

Another aspect provides a CPAP patient apparatus for reducing pressure on the major pressure points of the head as compared to prior strapping systems in which straps under tension are stretched around the patient's head to hold the CPAP mask properly on the patient's face.

Another aspect of an embodiment of the present invention provides a helmet having hinges on the side transverse elements connecting the transverse elements to the rear of the helmet. When the helmet is used on a patient, the transverse element encircles the skull from the rear of the helmet and encircles a portion of the temporal bone. The transverse elements are sometimes referred to herein as the wings of the helmet. A hinge connects each side wing to the rear portion of the helmet and enables the side wings to expand outwardly relative to the rear portion of the helmet for convenient removal from and placement on the head of a patient.

Another aspect provides a deformable pad inside the helmet for cushioning the head and conforming to the shape of the infant's head. The cushion may be, for example, a viscoelastic polyurethane foam, such as memory foam, with or without a liquid-proof silicone rubber band or any type of padding.

Another aspect of embodiments of the present invention provides a removable/washable cotton pad liner attached to an inner surface of a helmet.

Yet another aspect provides for an infant weight range for the helmet between about 500g to 1000g and 1000g to 1500g to accommodate head growth without causing excessive stress to the helmet, with larger sized helmets capable of accommodating larger child and adult head sizes.

Yet another aspect provides a helmet that expands as the head grows without twisting.

Another aspect of the invention provides a helmet that can cover only portions of the sides and back and top of a patient's head and/or has areas of bregma exposure for application of an ultrasound probe.

An aspect of the embodiments provides apertures (sometimes referred to as slits) in the side flaps, for example, providing a plurality of apertures/slits to determine the optimal angle at which to place a restraining strip connected to a mask or patient interface device relative to the patient's nose and/or patient's airway interface or mask and selecting the optimal restraining force as seen in table I. The holes may also be used to secure the eye mask in a desired position, covering the patient's eyes during phototherapy, while minimizing or removing pressure on the patient's cheeks caused by the eye mask straps that extend around the head and stretch over the cheeks to secure the eye mask in place. An ear cover for noise reduction may be removably attached to the side flap ear hole or opening. Another embodiment provides the use of a cleat or tie rod with a notch on a helmet for securing a leash or eye shield strap to the helmet. Alternatively, Velcro on the helmet may interact with the restraining straps for proper fastening of the straps and attached mask to the face. The lateral cross member wraps around the side of the head and covers a portion thereof (temporal, mastoid and maxillofacial regions) and over the patient's ears with minimal visual restriction to the patient.

Another aspect of the invention is that the helmet and liner may be made of biocompatible hypoallergenic materials. Yet another aspect of the invention provides for no measurable moisture retention in the liner and/or helmet, and the ability to be used near the head for electroencephalography (EEG). It is a further aspect of embodiments of the present invention to provide a patient airway interface system that maintains the natural curvature of a toddler's head.

Drawings

The accompanying drawings, which are incorporated in and form a part of the specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for purposes of illustrating one or more preferred embodiments of the invention and are not to be construed as limiting the invention. In the drawings:

fig. 1 is a right side view (from the perspective of the wearer) of a helmet having an inner liner according to one embodiment of the present invention.

Fig. 2 is a right side view of the helmet of fig. 1 without the liner.

Fig. 3 is a left side view of the helmet of fig. 2.

Fig. 4 is a front view of the helmet of fig. 2.

Fig. 5 is a perspective view of the left side of the helmet of fig. 2.

Fig. 6 is a view of a patient wearing a headgear assembly according to one embodiment of the present invention.

Figures 7A-C are views of a patient wearing a helmet according to one embodiment of the present invention.

Figure 8 is a graph of functional analysis and pressure point comparison produced by a helmet according to one embodiment of the present invention and a prior art restraint system.

Fig. 9 is a diagram of a neonatal neck placement for optimal airway location.

Figure 10 is a diagram of a front view of a headgear assembly according to one embodiment of the present invention positioned on a patient.

Fig. 11 is a diagram of a side view of a headgear assembly with a patient airway interface resting on an airway support tether/connector.

Fig. 12 is a rear view of a helmet according to one embodiment of the present invention positioned on a patient.

Fig. 13 is a view of a prior art strap, patient airway interface, and airway interface binder attached to a helmet.

Fig. 14A and 14B show another embodiment of the helmet, in which the lateral transverse elements do not cover the ears.

Fig. 15A and 15B provide additional views of the helmet according to fig. 14A.

Fig. 16A and 16B illustrate the helmet of fig. 14A with an earmuff or eyecup attached, according to one embodiment of the invention.

Fig. 17 is another embodiment of the helmet wherein the side cross members cover the ears.

Fig. 18 is another embodiment of a helmet wherein the top covers a larger portion of the skull.

Fig. 19 is another embodiment of the helmet wherein the side cross members extend from the top of the helmet.

Fig. 20 is another embodiment of a helmet wherein the top is expandable.

Fig. 21 is another embodiment of the helmet wherein the side cross members extend from the top of the helmet.

Fig. 22 is another embodiment of a helmet.

Fig. 23 is another embodiment of a helmet.

Fig. 24 is another embodiment of a helmet having a liner.

Fig. 25 is another embodiment of a helmet having a liner.

Fig. 26 is a side view of the helmet of fig. 25.

Fig. 27 is another embodiment of a helmet.

Fig. 28 is a side perspective view of the helmet of fig. 26.

Fig. 29 is a top view of the helmet shown in fig. 28.

Fig. 30 is a front view of the helmet of fig. 28.

Fig. 31 is a rear view of the helmet shown in fig. 30.

Fig. 32 is a right side view of the helmet of fig. 28.

Fig. 33 is a perspective view of the helmet of fig. 28.

Fig. 34 is a graphical view of an embodiment of the invention with measurements for a neonate.

Fig. 35 is a sectional view a-a of fig. 34 with measurements for a neonate.

Fig. 36 is a B-B sectional view of fig. 35 with measurements for a neonate.

Detailed Description

As used herein, an indefinite article "a" or "an" means one or more unless otherwise specified.

As used herein, "patient" means a neonate, an infant, a child, or an adult.

Referring now to fig. 1, one embodiment of a helmet 101 is shown. The helmet has a recess at the top 107, a rear portion 121, and right and left

side cross members

116, 113, sometimes referred to herein as helmet wings. The helmet recess is designed to cradle the head of a wearer. The helmet at least partially covers the top, back and sides of the patient's skull and conforms to the normal contour of the patient's skull while maximizing exposure of the face. In one embodiment, the helmet does not completely cover the skull of the patient. The helmet is made of a rigid outer shell such as ABS. There is a pad 122 that prevents the rigid outer shell of the helmet from contacting the face. The padding 122 may comprise a cloth lining covered with a pliable material that deforms upon application of pressure, such as from the weight of a patient's head resting on the inner surface of the helmet. In this embodiment, the helmet does not completely cover the frontal, parietal and occipital regions of the skull. In one embodiment, the back portion is designed to cover the medial back of the head and extend over the top of the infant's head. The front crown of the helmet terminates at the upper forehead of the frontal bone. The front edge of the front top portion comprises a stabilizer 111 on which a conduit carrying a fluid, such as a gas, will rest and/or to which it is fastened by means of a conduit bracket (not shown) that may be attached to the stabilizer. In one embodiment, the stabilizer 111 extends upward and/or downward from the front edge of the top portion. The lateral side elements extend around each side of the helmet. The lateral side members may be of the same or different rigid material as the rigid material forming the rear of the helmet. Each lateral side element is curved from the rear side of the helmet when the helmet is on the patient's head and extends around the front of the face over at least a portion of the patient's cheekbones, while the rigid shells of the lateral side elements do not directly contact the patient when the patient is lying in a supine position. The top of the helmet may have an opening 105 through which the top of the head may be accessed. There is an open space between the top and the lateral side elements of the helmet. There is an opening/slit 119 in one or both of the transverse side elements, for example in the front part of the transverse side element. Ear openings 117 are located in each of the lateral side members of the helmet. The ear opening may be covered to protect the patient's ear from noise.

Referring now to fig. 2, a right side view of a helmet 201 according to one embodiment of the present invention is shown. The right side cross member 209 is shown with cut-outs 207 that are located on the ears when the helmet is worn by the patient. The opening may be blocked with a pad to reduce noise from the environment in which the patient is located. An opening 213 is located at the front end of the first lateral side member to tether a strap for supporting a mask or nasal cannula to the patient's face. The stabilizer 205 may be shaped to extend above and below the front edge of the top 203 of the helmet. Ear openings 207 may be covered to protect the ears as desired.

Referring now to fig. 3, a left side view of the helmet of fig. 2 is shown, according to one embodiment of the present invention. In this embodiment, the left side view is the same as the right side view, but is not limited thereto, as each side can be designed with unique features (e.g., more cushioning, or no ear openings).

Referring now to fig. 4, a front view of a helmet according to one embodiment of the present invention is shown. Helmet 401 has a top 403 with a stabilizer 205 at the front edge. The stabilizer has a surface area facing the front of the helmet and greater than the top front edge of the helmet. The frame of reference of the right and left sides of the helmet is relative to the perspective of the patient when the helmet is used on the patient. The right and left transverse elements may be identical or different.

Referring now to fig. 5, a perspective view of the helmet 501 of fig. 2 is shown, according to one embodiment of the present invention. The helmet shown exhibits a concave rigid outer shell/exoskeleton and can be made of plastic such as ABS filaments. The top of the helmet has an opening 503. The rear side 202 of the helmet is connected to the

lateral side elements

211 and 409.

Referring now to fig. 6, there is shown a helmet 601 according to one embodiment of the present invention, comfortably positioned on the head of a neonatal patient. The patient airway interface 613 extends from the tube 615 to the nostrils of the nose. The conduit at the distal end "D" is held away from the face by a stabilizer 602, and the patient airway interface at the proximal end "P" of the conduit is supported by airway support bands 611 that position the patient airway interface 613 in the proper location of the neonate's nares for gas to flow from the conduit into the neonate's nares. The stabilizer holder is connected to the bushing 603. The conduit passes through an opening in the liner. The liner supports the conduit as it passes down over the top of the helmet. The liner holds the conduit a distance from the forehead of the patient and allows the conduit to be positioned a distance in front of the patient's face and prevents the upper portion of the conduit extending from the bottom of the liner from contacting the face of the neonate at the forehead. For example, the conduit is in contact with or in close proximity to the neonate's nose/nares at the distal end of the conduit through the patient airway interface 613. Alternatively, when the system is used to deliver fluid to or from the stomach, such as through an endotracheal tube, the tube is in contact with the mouth. A strap 609 is placed around the side of the helmet and through the slit/opening 608 in the front of the lateral side member to place the patient airway interface in place at a distance from the neonate's face/nostrils. The patient airway interface rests on airway support bands 611 passing under the end of the catheter and between the wings. The patient airway interface 613 directs the gas to the neonate's nares. In addition, the helmet is open at the top to perform the approximation for bregma ultrasound. The helmet allows proper CPAP function and effective tethering, and may support endotracheal tubes. The helmet includes padding 605 to space the rigid helmet from the skull and facilitate a tight fit. If the padding is moist and in a warm environment, it may grow bacteria. Often, the secretions reach the pillow and require easy access by the nurse to clear the secretions. Thus, a removable pad may be included for complete disposal and replacement of the dunnage. Alternatively, a silicon layer between the memory foam and the cloth may be added as a protective layer that can be wiped clean with only the cloth covering the pad to be replaced.

Referring now to fig. 7A, a headgear assembly system is shown positioned on a patient's head. Assembly 701 includes a conduit 703 supported distally by a stabilizer 709 and proximally by an airway support 717 at a patient airway interface 707. Airway support 717 is attached to chordae 713 on both sides of the catheter. The tether 713 is threaded through one of a plurality of openings 715 in the right side cross member 711 and the left side cross member 705. When the strap is a strip having ends connected to the right and left ends of the airway support 717, the strap may extend around the rear of the helmet. Alternatively, the right and left straps are attached or anchored to the helmet itself, and there is no need to stretch the straps around the back of the helmet to apply tension to the straps to keep the patient airway interface at a distance from the face to support the patient airway interface 707 in contact with the nares.

Referring now to fig. 7B, a headgear assembly 701 is shown showing airway support 717 for patient airway interface 707 positioned by a guide at a lower surface of the patient airway interface. The right and left ends of the airway support are attached to the ends of a strap 712 that passes from the outside of the helmet to the inside of the helmet through the openings of the right and left cross members. The strap is secured to the helmet to apply tension to the strap and to place the airway support at a distance from the face below the nose to stabilize the conduit and the patient airway interface for efficient delivery of gas into the nares. A gas delivery hose 716, such as of the type used with CPAP, passes over the top of the helmet and is connected to the top of a conduit that extends beyond the upper surface of the bushing/guide 709 attached to the stabilizer. Referring now to fig. 7C, headgear assembly system 701 illustrates another embodiment in which straps 712 connected to patient airway interface supports 715 do not pass through openings of the cross-member, but are located outside of the headgear.

Referring now to fig. 8, pressure points at positions a (forehead of the frontal bone position of the skull), B (mid-posterior of the parietal bone position of the skull), and C (cheek region of the zygomatic bone of the skull) of a neonate are measured by a helmet according to an embodiment of the invention while positioned on a real human-sized neonate. The pressures at each point are shown in table I. The pressure at the determined location of the restraint system holding the mask to the face without the helmet is measured and compared to the pressure at the determined location when the helmet is on the doll. The helmet has a minimum pressure at the determined position when it is on the doll head compared to the pressure at the determined position when the restraint system is on the doll head.

	Current binding pressure	CPAP helmet
			Measuring point
A	5.90460	0.0000
			B	4.997270	0.04127
C	5.14279	0.0000

TABLE 1

Referring now to fig. 9, the neck position of the neonate significantly affects airflow through the trachea. It is important that the heads are as aligned as possible. The helmet promotes proper neck alignment, facilitating unaffected air flow through the trachea. Newborns have little head position to allow for unaffected airflow through the trachea. It is important to keep the heads as aligned as possible. Buckling was prevented by placing a small roll of cloth under the neonate's neck. The degree of flexion of the placement can be adjusted by a gusset or padding placed on the lower edge of the rear portion of the helmet.

Referring now to fig. 10, a helmet assembly 1001 is shown in which a hose 1002 for transporting gas is attached to the top end of the conduit, the hose 1002 passing from above the helmet down through a guide/bushing 1005 attached to a stabilizer 1003. The catheter may be placed relative to the neonate's nares by moving the catheter up or down (craniocaudally) through the guide/bushing. The distal end of the conduit is a patient airway interface that may be placed over the nostrils of the neonate and secured in this position by having the distal end of the conduit rest on airway support 1019 secured to the side of each

transverse element

1011 and 1009 of the helmet with straps 1017. The strap 1017 is threaded through an opening or slit in one side of the right transverse element from outside to inside the helmet. The strap is attached to the right end of the patient airway interface support. A left strap 1018 passes from the outside of the helmet through a slot in the left cross member and is connected to the left end of the patient airway interface support.

Straps

1017 and 1018 are secured to the outside of the helmet. The anterior-posterior position of the patient airway interface relative to the nares and the left-right position of the patient airway interface relative to the nares and the cranio-caudal position of the patient airway interface relative to the nares may be adjusted by adjusting the length of the conduit passing under the bushing and the tension applied to the strap which results in a force pulling the patient airway interface posteriorly and into the face against the nares. In a preferred embodiment, sufficient tension is applied to the strap to maintain the patient airway interface in position at the nares. Fig. 11 to 12 show the helmet in side and rear views, respectively. Fig. 11 shows the gas hose 1103 positioned above the top 1109 of the helmet. For example, the gas hose may be connected to a device that facilitates breathing, such as CPAP, or a device that delivers various concentrations of oxygen. The position of the strap 1119 on the headgear and the fastening of the patient airway interface 1113 by the patient airway interface support 1121 is shown in this side view. Fig. 12 shows a rear view of a helmet with, for example, a strap or eye shield anchored to the helmet by, for example, Velcro 1205. Velcro 1205 may be placed on the outside of the helmet for attachment of a strap. The hinge 1209 is arranged at the rear of the helmet and the transverse element and may help to expand the transverse element when the helmet is arranged on or removed from the patient. The top 1207 of the helmet extends to the front of the head and terminates at the forehead of the frontal bone.

Referring now to FIG. 13, there is shown a catheter 1301 and an airway support 1307 and a cable assembly 1305 according to the prior art. The opening of the patient airway interface 1303 enables the patient airway interface to be placed at the nares or nearly touching the tip of the nose.

Referring now to fig. 14A, a helmet 1401 is shown in accordance with another embodiment of the present invention. The stabilizer 1403 has an accessory device, such as a Velcro 1405, on the front surface of the stabilizer. The bushing may be placed against the Velcro for positioning the catheter. In contrast to other embodiments disclosed herein, the left and right

lateral elements

1415, 1409 encircle the face and enable ear exposure, wherein the lateral side elements can cover the ears when there are no ear openings. The lateral side elements may be arranged in the direction of arrow 1411. The hinge 1413 allows the transverse element to be adjustable for arranging and removing the helmet from the head. Referring now to fig. 14B, a top view of the helmet 1401 is shown. There is an open area 1404 that may be oval, but is not limited thereto as any open geometry is acceptable. The right lateral element 1409 and the left lateral element 1415 are curved around and do not contact the front of the face.

Referring now to fig. 15, a helmet 1401 is shown. The curved rear portion 1503 is shown in this view. The helmet partially covers the occiput "O", parietal "P", frontal "F" and the transverse element covers the zygomatic "Z" and a portion of the temporal bone.

Referring now to fig. 15B, an interior view 1502 of a helmet 1401 has a liner 1503 on the inside. A foam pad 1505 is disposed against the inner rear portion of the helmet. When properly on the patient's head, the lower portion of the helmet is disposed over the occiput of the skull. The internal roof is designed to cover the parietal "P" and frontal "F" areas of the skull when properly on the patient. Note 1505 that padding may change the angle of head flexion.

Referring now to fig. 16A, a side view of a helmet 1401 with a removable ear cover 1602 is shown. Referring now to fig. 16B, a side view of 1401 is shown with removable ear cap 1604.

Referring now to fig. 17, a helmet 1701 is shown in accordance with an embodiment of the present invention in which lateral side element 1702 is shown covering a larger portion of the skull in the region of the temporal and zygomatic bones as compared to lateral side

lateral elements

1409 and 1415 of fig. 14. The hinges 1703 enable the side cross-member 1702 to move outwardly relative to the rear 1704 of the helmet.

Referring to fig. 18, a helmet 1801 according to another embodiment of the present invention is shown. In contrast to other embodiments of the invention described herein, the roof 1802 covers a larger portion of the frontal and parietal bones of the skull. An opening is present at the top for access to the head at the frontal bone portion of the skull.

Referring now to fig. 19, a helmet 1901 is shown with lateral side elements 1905 extending from the top of the helmet. The helmet is not curved at the rear 1903 that covers the occiput.

Referring now to fig. 20, a helmet 2001 is shown according to one embodiment of the present invention. A fore-aft adjuster 2003 is shown which enables expansion in the direction of the arrow at the front top 2005 of the helmet relative to the rear top of the helmet. The top expands to fit different head sizes. The transverse element extends from the rear of the helmet and is integral therewith.

Referring now to fig. 21, a helmet 2101 according to one embodiment of the present invention is shown. The movable mount 2105 is adjusted anteroposteriorly to position the transverse element closer or farther relative to the nose. The pad 2107 is disposed between the skull and the helmet frame. The circumference of the helmet is adjustable by an adjuster 2103. The stabilizer 2106 is disposed at the front of the helmet. In one embodiment, there is also a removable mount on the other side of the helmet.

Referring now to fig. 22, a helmet 2201 is shown according to one embodiment of the present invention. The molded pad 2203 spaces the helmet from the skull 2202.

Referring now to fig. 23, a helmet 2301 is shown according to another embodiment of the invention. A securing strap 2303 is attached to the transverse element 2305 and the top 2302 of the helmet.

Referring now to fig. 24, a helmet 2401 is shown according to another embodiment of the invention. The bushing 2403 is attached to a stabilizer 2405 at the top of the helmet. The stabilizer has a large area 2405 at the front of the helmet that can be covered completely or partially with Velcro. Open area 2406 is at the top of the helmet. Lateral side elements 2409 extend from the rear of the helmet.

Referring now to fig. 25, a helmet 2501 is shown according to one embodiment of the present invention. The bushing 2503 is attached to the stabilizer 2505. The bushing may be foam or molded plastic and may be attached to the stabilizer by Velcro on the stabilizer surface or with tabs. The bushing 2503 is t-shaped with tabs that can be folded over the helmet front edge to secure the bushing in place. The bushing includes an opening that securely holds the catheter in place once the catheter is disposed therein. The liner opening may be adjustable to accommodate different sized conduits.

Referring now to fig. 26, a right side view of a helmet 2501 is shown. The hinges 2609 allow the lateral side members 2606 flexibility away from the face for positioning the helmet on the head. Additionally, Velcro or other attachment means 2609 may be placed to the sides of the elements for securing the patient airway device's chordae and/or ear or eye cups against the facial arrangement. The rear portion 2611 of the helmet is spaced from the lateral side members 2606 by a partition 2608. The front part of the helmet is arranged at the lower part of the forehead. The tabs 2603 attached to the bushing 2605 are shown in a pre-secured position. The front surface 2607 of the helmet is used to stabilize the liner.

Referring now to fig. 27, a helmet 2701 is shown according to one embodiment of the invention. A top 2703 is shown with an open area at the top end 2707. The rear portion 2709 is curved and is connected to the

lateral side elements

2713 and 2715 by hinges 2711. A seam 2710 separates the rear portion from the top portion 2703. A stabilizer 2705 is shown in the front top of the helmet.

Referring now to fig. 28, a helmet 2801 is shown according to one embodiment of the present invention. A top 2809 with a seam 2810 and a sleeve 2807 for a conduit is attached to the front of the helmet. The front of the helmet may be covered by Velcro. The bottom of the helmet is curved 2813 and the lateral side elements are hinged 2811 to the back of the helmet.

Referring now to fig. 29, a top view of the helmet of fig. 28 is shown. A hub 2903 for a catheter is seen, having an open area 2902 through which the catheter passes. The open area in the top 2907 of the helmet enables access to the head in the area of the frontal bone. The bushing is attached to the front surface of the helmet top.

Referring now to fig. 30, a helmet 3001 according to another embodiment of the present invention is shown. The front, in the view of the bushing 3003, is attached to the front of the helmet. The Velcro covers all or a portion of the front of the helmet and attaches the sleeve to the helmet.

Referring now to fig. 31, the rear portion of the helmet 3001 is shown 3101. An opening 3107 in the top 3105 of the helmet allows access to the skull. Also shown are a back 3103 and a hinge 3109.

Referring now to fig. 32, a side view of the helmet 3001 is shown with a bushing 3203 associated with a front surface 3205 of a top 3207 of the helmet. The top of the head is accessible through an opening 3209 of the helmet. The rear portion 3211 is spaced from the right side transverse element 3215 by a seam 3212.

Referring now to fig. 33, a perspective view of a helmet 3001 is shown with a bushing 3203 attached to a front surface 3205 of the helmet.

Referring now to fig. 34, a diagram of a helmet according to an embodiment of the present invention with measurements of a newborn's head is shown. As shown, distance d¹The distance of the outer edge of the top of the helmet. As shown, distance d²Is the distance between two points of the inner edge of the right-hand transverse element and the left-hand transverse element. Distance d³Is the distance between the lateral transverse elements at the front curve. As shown, distance d⁴Is the distance between the front edges of the rear vertical cross-sections of the transverse side elements.

Referring now to fig. 35, a graph of the helmet according to fig. 34 (a-a cut) with measurements of the neonatal head is shown. As shown, distance d¹Is the distance between the inner curve of the top of the helmet and the curve at the back of the helmet. As shown, distance d²Is the distance between the front edge of the transverse side element and the rear part of the helmet where it ends. As shown, distance d³Is the distance between the forwardmost point in the helmet opening and the rear portion of the helmet bottom where it ends. As shown, distance d⁴Is the distance between the lower front edge of the helmet and the middle of the lateral side elements. As shown, distance d⁵Is the distance between the bottom surface of the front edge of the helmet and the top surface of the front edge of the helmet. As shown, distance d⁶Is the distance between the front edge of the vertical part of the transverse side element and the front surface of the front edge of the transverse side element. As shown inThe curvature of the helmet is represented by radii at several locations around the top and back of the helmet.

Referring now to fig. 36, a graph of the helmet according to fig. 34 (B-B cut plane) with measurements of the neonatal head is shown. Distance d¹Is the distance between the rear edges of the transverse side elements. As shown, distance d²Is the distance between the ends of the transverse side elements at the inner surface. As shown, distance d³Is the distance between the front inner surfaces of the transverse side elements. The dimensions illustrated in fig. 34-36 may be increased proportionally to increase the larger head size, providing measurements that are approximate and may vary over the range (+/-20%).

Although the invention has been described in detail with particular reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art, and the appended claims are intended to protect all such variations and modifications. For example, the helmet may be adjustable to accommodate various sizes of skull. The helmet may be made of plastic or composite materials made of acrylonitrile butadiene styrene, high density polyethylene, polyurethane, nylon, polycarbonate, polypropylene, or any combination thereof, but is not limited thereto. The complete disclosures of all documents, applications, patents, and publications cited above are incorporated herein by reference.

Claims

1. A headgear for securing a patient airway interface device to a patient's head, comprising:

a rigid concave partial helmet having an outer surface and an inner surface, and having a left transverse element, a right transverse element, a top, and a back, wherein the left and right transverse elements are spaced apart at a front half of the rigid concave partial helmet by a gap between the top front half of the rigid concave partial helmet and the left and right transverse elements;

the top portion of the rigid concave partial helmet terminates at the forehead of the patient's head when on the patient's head, the rigid concave partial helmet having a stabilizer for supporting the bushing in front of the top portion adjacent the forehead, wherein the left and right cross members are configured to terminate on either side of the patient's face covering the cheek without directly contacting the cheek, wherein the portions of the right and left cross members covering the cheek include openings that allow the strap to pass from the outer surface to the inner surface, wherein the portion of the inner surface of the rigid concave partial helmet configured to cover the back half of the skull when the headgear is in use is spaced from the patient's head by a pliable material attached to the inner surface of the rigid concave partial helmet.

2. Headgear according to claim 1 wherein the top of the rigid concave partial helmet comprises an open portion to allow access to the fontanel region of the patient's head.

3. Headgear according to claim 1 wherein the left and right transverse elements of the rigid female partial helmet cover the ears and comprise a removable noise-inhibiting cover which when removed leaves an opening at a location above the ears of the left or right transverse element.

4. The headgear of claim 1 wherein a rear portion of the rigid concave partial helmet is configured to cover an occipital region of a patient's head.

5. The headgear of claim 1 wherein the left transverse element of the rigid concave partial helmet and the right transverse element of the rigid concave partial helmet are movably connected to the rear portion of the partial helmet with a connector.

6. The headgear of claim 5 wherein the connector is a hinge.

7. Headgear according to claim 1 wherein the pliable material is releasably connected to the inner surface, the pliable material in use remaining adapted to the natural shape of the head.

8. Headgear according to claim 1 wherein the pliable material is covered by a washable liner.

9. A gas delivery system adapted to provide a flow of gas to an airway of a patient, the system comprising:

headgear for securing a patient airway interface to a patient's head, the headgear comprising the rigid concave partial helmet of claim 1; and

a gas delivery conduit comprising a patient airway interface having an airway interface support for delivering gas under pressure to nares, the airway interface support having a strap for securing the patient airway interface to the rigid concave partial helmet at a location relative to the nares of the patient.

10. The gas delivery system of claim 9, wherein the strap is secured to the rigid concave partial helmet through an opening in a left transverse element of the rigid concave partial helmet and a right transverse element of the rigid concave partial helmet.

11. The gas delivery system of claim 10, wherein the opening is a plurality of openings at different locations on a right cross member of the rigid concave partial helmet and a left cross member of the rigid concave partial helmet, the plurality of openings for selecting an optimal angle for securing the patient airway interface with respect to the patient's nares.

12. The gas delivery system of claim 9, wherein the gas delivery conduit is attached to the rigid concave partial helmet by a bushing attached to a stabilizer on a front portion of the rigid concave partial helmet, the bushing having an opening, the gas delivery conduit passing through the opening in the bushing to the bushing at an angle such that a patient airway interface at the first end of the gas delivery conduit is directly adjacent to a nostril of a patient wearing the rigid concave partial helmet.

13. The gas delivery system of claim 9, wherein the gas delivery conduit extends above the liner at a second end.

14. The gas delivery system of claim 9, wherein the eye shield can be tethered to the rigid concave partial helmet when the patient is in need thereof.